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Clinical Trials in the UK / NCT07003919
Active, not recruiting Phase 3

Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

NCT07003919 · tracked via the Priya Life Science UK tracker
Sponsor
DBV Technologies
Phase
Phase 3
Started
2025-06-24
Last updated
2026-07-22

Condition(s) studied

AllergyPeanut Allergy

Investigational drug(s) / intervention(s)

DBV712 250 mcgPlacebo

DBV712 250 mcg: DBV712 250 mcg epicutaneous system.

Placebo: DBV712 matching placebo epicutaneous system.

Study summary

The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.

Eligibility

Sex
ALL
Min age
1 Year
Max age
3 Years
Healthy volunteers
No
Key Inclusion Criteria: * Aged 1 through 3 years at Visit 1 (screening). * Physician-diagnosed peanut allergy and following a strict peanut-free diet * Peanut-specific IgE \> 0.7 kUA/L. * A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening). * An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC). Key Exclusion Criteria: * Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut. * Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region). * Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy). * History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT). * Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1. * Uncontrolled persistent asthma.

Primary outcome measure(s)

Trial sites (91)

FacilityCityRegionStatus
AllerVie Clinical Research Birmingham Alabama
University of Alabama at Birmingham Pediatric Primary Care Clinic Birmingham Alabama
Modena Allergy & Asthma Scottsdale Arizona
University of Arizona Asthma and Airway Disease Research Center Tucson Arizona
Arkansas Children's Hospital Little Rock Arkansas
Modena Allergy & Asthma La Jolla California
Modena Allergy and Asthma Long Beach California
UCLA Health Westwood Pediatrics Los Angeles California
Children's Hospital of Los Angeles Los Angeles California
Allergy & Asthma Associates of Southern California Mission Viejo California
Lucile Packard Children's Hospital Stanford Palo Alto California
Allergy & Asthma Medical Group and Research Center San Diego California
Rady Children's Hospital - San Diego San Diego California
Orso Health Torrance Torrance California
Children's Hospital Colorado Aurora Colorado
Asthma & Allergy Associates Colorado Springs Colorado
Children's National - Main Hospital Washington D.C. District of Columbia
University of South Florida Children's Research Institute St. Petersburg Florida
Allergy, Asthma & Immunology Associates of Tampa Bay Tampa Florida
Emory University - Children's Healthcare of Atlanta, Inc. Atlanta Georgia
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
University of Chicago Medicine Comer Children's Hospital Chicago Illinois
Sneeze, Wheeze and Itch Associated, LLC Normal Illinois
Deaconess Clinic - Downtown Evansville Evansville Indiana
Riley Hospital for Children at Indiana University Health Indianapolis Indiana
The University of Kansas Health System - Main Campus, Medical Pavilion Kansas City Kansas
Johns Hopkins Hospital Baltimore Maryland
Allergy Asthma Specialists of Maryland - White Marsh White Marsh Maryland
MassGeneral Hospital for Children Boston Massachusetts
Boston Children's Hospital Boston Massachusetts
Regents of the University of Michigan Ann Arbor Michigan
Allergy and Immunology Associates of Ann Arbor Ann Arbor Michigan
Allergy and Asthma Research Center of Minnesota Maplewood Minnesota
Mayo Clinic Rochester Minnesota
Children's Mercy Hospital Kansas City Missouri
St. Louis Children's Hospital St Louis Missouri
Weiss Medical Riverdale New Jersey
Northwell Health Allergy and Immunology at the Irving Goldman Family Care Center Great Neck New York
NYU Langone Health New York New York
Equity Medical New York New York

+ 51 more sites — see the full list on the official registry below.

More DBV Technologies trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07003919 on ClinicalTrials.gov ↗ ← All trials in the UK